LOTRIMIN ANTIFUNGAL- miconazole nitrate aerosol, powder

Lotrimin by

Drug Labeling and Warnings

Lotrimin by is a Otc medication manufactured, distributed, or labeled by Bayer Healthcare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

When using this product

• avoid contact with the eyes
• use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
• contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condition persists longer, ask a doctor
• this product is not effective on the scalp or nails
• in case of clogging, clean nozzle with a pin

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

isobutane, SD alcohol 40-B (8% v/v), stearalkonium hectorite, talc

Questions?

1-866-360-3266

Distribution

Distributed by: Bayer HealthCare LLC, Whippany NJ

PRINCIPAL DISPLAY PANEL - 133 g Can Label

Powder Spray

goes on dry

NDC: 11523-0544-2

LOTRIMIN® AF

ANTIFUNGAL

miconazole nitrate

Clinically Proven To Cure

Most Athlete's Foot

• Relieves Itching,
  
  Burning, Cracking
  
  & Scaling

NET WT 133g (4.6 OZ)

INGREDIENTS AND APPEARANCE

LOTRIMIN  ANTIFUNGAL
miconazole nitrate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0544
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0544-2	133 g in 1 CAN; Type 0: Not a Combination Product	09/01/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/01/1993

Labeler - Bayer Healthcare LLC. (112117283)